Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

August 2, 2011 updated by: Centre Hospitalier Universitaire Vaudois

Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy Volunteers

This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • age between 18 and 25 years old
  • no known pathology
  • normal physical exam
  • BMI between 20 and 25 kg/m2

Exclusion Criteria:

  • history of endocrine disease
  • no known infertility (no conception after 12 months of regular unprotected intercourse)
  • abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: isocaloric
impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary supplement: effect of metabolic variations on LH pulsatility

Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.

Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.

PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia.
Other: hypercaloric
impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary supplement: effect of metabolic variations on LH pulsatility

Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.

Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.

PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia.
Other: per os and IV glucose during the clamp
impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps
Dietary supplement: effect of metabolic variations on LH pulsatility

Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.

Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.

PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Luteinizing hormone (LH) pulsatility
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: François Pralong, CHUV
  • Study Director: Vittorio Giusti, CHUV
  • Study Director: Luc Tappy, CHUV
  • Study Director: Marie-Hélène Pesant, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Swiss national science fund
  • Grant number 320030-124886 (Other Grant/Funding Number: Swiss national science fund)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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